Chapter 1 - Introduction

• to record its growth and potential as a significant discipline within medical science, and

• to describe its impact on patient welfare and public health.

It highlights the need for critical examination of the strengths and weaknesses of present pharmacovigilance systems in order to increase their impact. It anticipates developments necessary to meet the challenges of the next ten years. It argues that the distinctive approaches adopted by different countries in response to their individual needs should be supported and fostered. The document also highlights the importance of collaboration and communication at local, regional and international levels, to ensure pharmacovigilance delivers its full benefits.

Pharmacovigilance and all drug safety issues are relevant for everyone whose life is touched in any way by medical interventions. The document is intended for the following, wide-ranging readership:

• Policy makers at all levels of healthcare, particularly those concerned with drug policy

• Staff and consultants in national drug regulatory authorities

• Healthcare practitioners including doctors, nurses and pharmacists

• Pharmaceutical industry executives and scientists

• Professional staff in national pharmacovigilance centres

• Editors of medical and scientific journals

• Health epidemiologists

• Health economists

• Professional staff of poison and drug information centres

• Health administrators

• Consumer groups and patient support groups

• Legal advisors in health care

• Schools of health sciences, and

• The concerned layperson.

COMMON ABBREVIATIONS USED IN THIS DOCUMENT:

ADR

Adverse Drug Reaction

ICH

International Conference on Harmonization

UMC

the Uppsala Monitoring Centre (The WHO Collaborating Centre for International Drug Monitoring)